FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00721902987267
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X1003430
Device description
TL BLADE-DISC-14X30-5SHP7.5TTH
Published
2022-10-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCUTTER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902987267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902987267007219029872677219029872670721902987267

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic knifeA hand-held manual surgical instrument designed for cutting/shaping bone during an orthopaedic surgical intervention. It is typically a heavy, one-piece instrument with a sharp, single-edged, strong cutting blade at the distal end available in various shapes and sizes, with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663129053Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCFZT2026-02-11
10889981087968GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087975GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087982GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981095970GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981106058CoralSeaspine Orthopedics CorporationFZT2025-12-19
10889981123932GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981259921NorthStarSeaspine Orthopedics CorporationFZT2025-12-19
03662663278096Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-18
03662663217699Vail OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-12-17
03662663266635Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266642Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266659Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266666Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266673Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266680Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266697Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
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03662663266727Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
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03662663266741Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
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03662663266765Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266772Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278799Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278805Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278812Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278829Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278836Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16